What's something that could potentially slow down the diagnoses of H1N1 otherwise known as Swine flu? Try a public health system that has to wait copious amounts of time to receive test results identifying the virus.
Quest Diagnostics (Madison, New Jersey) aims to speed up the process a bit. The company reported that its Focus Diagnostics (Cypress, California) infectious disease reference laboratory has introduced a laboratory-developed real-time polymerase chain reaction (PCR) test to aid in identifying Influenza A H1N1 Swine-origin (H1N1) flu virus.
The company said that the Focus Diagnostics Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test is the first laboratory testing service to be introduced by a commercial laboratory to aid in the identification of patients infected with the novel H1N1 virus and differentiate patients infected with other seasonal Influenza A strains. The company said that Focus Diagnostics has a track record of being first to market with new laboratory testing services for emerging infectious diseases, such as West Nile Virus, SARS, and chikungunya virus.
"This is potentially a much faster turn around time," Jay Lieberman, MD, Medical Director, Infectious Disease Quest Diagnostics told Medical Device Daily. "We can give results within 24 hours. Health departments aren't set up to be laboratories."
Focus Diagnostics validated its new Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test using clinical specimens submitted to its reference laboratory confirmed as positive for the novel H1N1 influenza virus by public health authorities. Real-time PCR is a highly sensitive testing technique that can detect the presence of a virus' RNA from a patient's nasal or nasopharyngeal specimen. The S-OIV virus responsible for a recent outbreak affecting dozens of countries is a subtype of Influenza virus Type A.
The new Focus Diagnostics test simultaneously detects the presence of Influenza A virus RNA and specifically identifies the presence of the novel H1N1 virus.
Focus Diagnostics will perform the Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR laboratory test, in alignment with current public health guidelines, at its reference laboratory in Cypress, California. Physicians, hospitals and other healthcare practitioners may order the laboratory test directly from Focus Diagnostics or through the Quest Diagnostics national laboratory network. Expected turnaround time for reporting results is within 24 hours of receipt of specimen by the Focus Diagnostics laboratory.
"Our new laboratory test will be an important tool to help health care professionals and public health authorities identify infected patients more quickly, promoting earlier diagnosis and treatment," said Jon Cohen, MD, senior VP and CMO, Quest Diagnostics. "This capability could be particularly important if the novel H1N1 virus continues to spread in the U.S. or re-emerges this fall or winter. Public health officials in the U.S. have done an exceptional job of managing the current Influenza emergency, and we continue to work closely with them to assist their preparedness efforts."
In addition to the new Influenza A H1N1 (Swine Flu) RNA Real-Time RT-PCR Test, Quest Diagnostics' regional laboratories, including the Focus Diagnostics reference laboratory, perform a broad range of testing services to detect Influenza viruses, including PCR, rapid cell culture, direct immunofluorescence (DFA) and enzyme immunoassay (EIA) techniques. Depending on the laboratory, the company can perform testing on different types of collected specimens, such as nasopharyngeal swabs, nasal secretions, nasal wash (lavage) and aspirations.
The price point for the test will be at $298 and is sure to be highly demanded.
Quest declined to talk about how many patients had already used the test but did say the volume of patients using it has been growing.
To date there have been at least 8,829 people sickened by the H1N1 in 40 countries, and up to 76 deaths from it.
"[H1N1] still remains a big story, Lieberman told MDD. "No one knows what's going to happen with this outbreak."